<?xml version="1.0" encoding="UTF-8"?>
<?xml-stylesheet type="text/xsl" href="https://digitalhealthconsult.com/wp-sitemap.xsl" ?>
<urlset xmlns="http://www.sitemaps.org/schemas/sitemap/0.9"><url><loc>https://digitalhealthconsult.com/2015/05/24/digital-health-and-fda-what-does-fda-intend-to-regulate-and-what-does-that-mean-for-my-digital-health-product/</loc><lastmod>2015-06-02T17:15:33+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2015/06/19/the-impact-of-fitbit-ipo-on-digital-health/</loc><lastmod>2015-06-19T03:28:42+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2015/08/07/ibms-watson-to-see-clinical-imaging-data-with-1b-acquisition-of-merge-healthcare/</loc><lastmod>2015-08-10T02:58:30+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2015/09/22/fitbit-announces-hipaa-compliance-for-wellness-platform/</loc><lastmod>2015-09-22T17:01:09+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2015/10/29/theranos-and-recent-fda-issues-a-cautionary-tale-on-the-need-for-regulatory-strategy/</loc><lastmod>2015-10-29T14:55:30+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2016/01/07/the-new-launchpad-for-mobile-medical-device-apps-the-consumer-electronics-show/</loc><lastmod>2016-01-07T23:48:35+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2016/03/08/ibm-buys-truven-for-2-6-billion-now-has-health-related-data-on-approximately-300-million-patient-lives-to-watson-health/</loc><lastmod>2016-03-08T17:37:42+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2018/01/21/signs-of-how-the-medical-device-world-is-changing-honda-now-has-a-medical-walking-assist-device/</loc><lastmod>2018-01-21T01:07:39+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2018/09/13/apple-watch-series-4-gains-two-fda-regulated-medical-device-products-in-a-week/</loc><lastmod>2023-08-25T17:02:33+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/08/08/ai-enabled-medical-devices-with-recent-fda-de-novo-or-510k-clearances/</loc><lastmod>2023-08-25T17:03:46+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/08/17/comments-on-fda-draft-guidance-related-to-predetermined-change-control-plan-for-artificial-intelligence-machine-learning-ai-ml-enabled-device-software-functions/</loc><lastmod>2023-08-25T17:04:36+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/08/24/follow-up-on-ai-enabled-medical-devices-with-recent-de-novo-classifications/</loc><lastmod>2023-08-25T17:01:37+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/09/22/commentary-on-draft-fda-guidance-titled-best-practices-for-selecting-a-predicate-device-to-support-a-premarket-notification-510k-submission/</loc><lastmod>2023-09-22T20:45:16+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/09/28/fda-transition-plan-in-action-as-demonstrated-by-akili-endeavorotc-product/</loc><lastmod>2023-09-28T23:54:19+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/09/29/late-breaking-news-fda-issues-proposed-rule-on-laboratory-developed-tests-ldts-outlines-plans-for-greater-oversight-of-ldts-and-eventual-phaseout-of-enforcement-discretion-approach-to-ldts/</loc><lastmod>2023-09-29T16:15:34+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/10/06/stakeholders-revise-call-for-congress-to-pass-valid-act-to-enable-fda-regulation-of-laboratory-developed-tests-ldts/</loc><lastmod>2023-10-06T16:29:16+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/10/19/cdrh-proposed-guidances-for-fiscal-year-2024-related-to-artificial-intelligence-machine-learning-ai-ml-enabled-device-software-functions/</loc><lastmod>2023-10-19T18:03:29+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2023/11/04/fda-warning-letter-issued-for-non-validated-ai-code-claimed-for-research-use-only/</loc><lastmod>2023-11-04T22:35:41+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2024/02/22/fda-warns-industry-about-potential-data-integrity-issues-with-third-party-testing-laboratories/</loc><lastmod>2024-02-22T23:23:30+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2024/02/22/fda-reminds-public-that-any-smartwatches-or-rings-claiming-to-measure-glucose-are-not-fda-authorized/</loc><lastmod>2024-02-22T23:37:33+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2024/05/20/fda-de-novo-classifies-the-first-product-that-scans-electronic-health-record-to-identify-those-at-risk-of-developing-sepsis/</loc><lastmod>2024-05-20T19:07:20+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2025/08/11/artera-receives-fda-breakthrough-designation-for-ai-prostate-test/</loc><lastmod>2025-08-11T21:57:57+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2025/08/11/illinois-prohibits-the-use-of-ai-to-provide-mental-health-and-therapeutic-decision-making/</loc><lastmod>2025-08-11T22:00:06+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2025/08/12/a-false-claims-act-fca-suit-due-to-not-meeting-fda-cybersecurity-requirements-and-the-implications-on-other-possible-fca-actions/</loc><lastmod>2025-08-12T21:21:47+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2025/12/09/advamed-and-abbott-request-that-fda-center-for-devices-and-radiological-health-cdrh-withdraw-entirely-certain-guidances-and-prioritize-other-guidances-in-fiscal-year-2026/</loc><lastmod>2025-12-10T00:17:05+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2025/12/18/proposed-amendment-to-eu-mdr-could-relax-rules-on-ai-medical-device-software/</loc><lastmod>2025-12-18T16:08:20+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2026/01/06/fda-releases-update-to-general-wellness-policy-for-low-risk-devices-guidance-with-major-changes-in-favor-of-general-wellness-space/</loc><lastmod>2026-01-06T22:56:35+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2026/01/07/fda-releases-update-to-clinical-decision-support-software-guidance-that-expands-non-regulated-opportunities-particularly-for-ai-industry/</loc><lastmod>2026-01-07T23:08:55+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2026/02/12/fda-holds-virtual-town-hall-meeting-on-recent-general-wellness-guidance-update/</loc><lastmod>2026-02-17T21:23:38+00:00</lastmod></url><url><loc>https://digitalhealthconsult.com/2026/03/12/fda-holds-virtual-town-hall-meeting-on-clinical-decision-support-guidance-update/</loc><lastmod>2026-03-13T15:18:59+00:00</lastmod></url></urlset>
